Teva Announces FDA Approval of QVAR® RediHaler™ (Beclomethasone Dipropionate HFA) Inhalation Aerosol
August 07 2017 - 8:00AM
Business Wire
Maintenance Treatment Option Designed to
Eliminate the Need for Hand-Breath Coordination During
Inhalation
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA)
announced today that the U.S. Food and Drug Administration (FDA)
has approved QVAR® RediHaler™ (beclomethasone dipropionate HFA)
inhalation aerosol, a breath-actuated inhaler for the maintenance
treatment of asthma as a prophylactic therapy in patients 4 years
of age and older. QVAR® RediHaler™ is not indicated for the relief
of acute bronchospasm. The product is expected to become
commercially available in both 40mcg and 80mcg strengths to
patients by prescription during the first quarter of 2018.
QVAR® RediHaler™ differs from conventional metered-dose inhalers
(MDIs) as it delivers medication via a breath-actuated MDI,
eliminating the need for hand-breath coordination during
inhalation. QVAR® RediHaler™ administers the same active drug
ingredient found in QVAR® (beclomethasone dipropionate HFA)
Inhalation Aerosol, with a different mode of delivery. In addition,
QVAR® RediHaler™ is designed to be used without shaking or priming.
It should not be used with a spacer or volume holding chamber.
“When working to manage asthma on a daily basis, proper
administration of medication is of paramount importance,” said Dr.
Warner W. Carr, MD, Associate Medical Director of Southern
California Research at Allergy and Asthma Associates of Southern
California Medical Group in Mission Viejo, California. “However,
research has indicated that approximately 76 percent of patients
still struggle to use their MDI inhalers correctly1, thus placing
them at increased risk for asthma exacerbations. From a clinical
perspective, QVAR® RediHaler™ is a much-needed treatment option for
these patients who may be experiencing continued difficulty with
hand-breath coordination.”
“It’s important that we uncover new opportunities to take
longstanding, clinically effective medications, such as QVAR®, and
incorporate them into device technologies that may help address key
ongoing issues for patients, including inhaler technique,” said
Tushar Shah, MD, Head, Late Stage Development at Teva
Pharmaceuticals. “The FDA approval of QVAR® RediHaler™ brings to
market inhaler technology aimed at enabling patients to more
accurately administer the medication and ensuring they are
receiving a proper dose with each inhalation.”
QVAR® MDI with dose counter, the currently available form of
QVAR®, was originally approved by the FDA in 2014. Teva plans to
discontinue sales of this current QVAR® MDI formulation upon the
launch of QVAR® RediHaler™ in the first quarter of 2018. Patients
and caregivers are encouraged to speak with a healthcare
professional about how this transition may impact their current
treatment plan.
This approval is supported by Teva’s clinical development
program for QVAR® RediHaler™, which includes data from one Phase I
and four Phase III studies that evaluated the safety and efficacy
of the product in asthma patients ages four years and older.
IndicationQVAR® RediHaler™ (beclomethasone dipropionate
HFA) Inhalation Aerosol is indicated for the maintenance treatment
of asthma as prophylactic therapy in patients 4 years of age or
older.
Important Limitation of Use: QVAR RediHaler Inhalation Aerosol
is NOT indicated for the relief of acute bronchospasm.
Important Safety Information
- Contraindications: QVAR
RediHaler is contraindicated in:
- Primary treatment of status asthmaticus
or other acute episodes of asthma where intensive measures are
required
- Patients with known hypersensitivity to
beclomethasone dipropionate or any of the ingredients in QVAR
RediHaler
- Localized infections: Infections
with Candida albicans have occurred in the mouth and pharynx in
some patients receiving QVAR RediHaler. Advise rinsing of mouth
with water without swallowing after use. If oropharyngeal
candidiasis develops, QVAR RediHaler may need to be temporarily
interrupted under close medical supervision
- Deterioration of asthma and acute
episodes: Do not use QVAR RediHaler for the relief of acute
symptoms. Instruct patients to contact their physician immediately
if episodes of asthma that are not responsive to bronchodilators
occur during the course of treatment with QVAR RediHaler
- Transferring Patients from Systemic
Corticosteroid Therapy: Particular care is needed in patients
who are transferred from systemically active corticosteroids to
QVAR RediHaler because deaths due to adrenal insufficiency have
occurred in asthmatic patients during and after transfer from
systemic corticosteroids to less systemically available inhaled
corticosteroids. Taper patients slowly from systemic
corticosteroids if transferring to QVAR RediHaler
- Immunosuppression: Patients who
are on drugs that suppress the immune system, such as
corticosteroids, are more susceptible to infections than healthy
individuals and should avoid exposure to chicken pox or measles.
Inhaled corticosteroids should be used with caution, if at all, in
patients with active or quiescent tuberculosis infection of the
respiratory tract; untreated systemic fungal, bacterial, parasitic,
or viral infections; or ocular herpes simplex
- Paradoxical Bronchospasm:
Inhaled corticosteroids may produce inhalation-induced bronchospasm
with an immediate increase in wheezing after dosing that may be
life-threatening. If this occurs with QVAR RediHaler, it should be
treated immediately with an inhaled, short-acting bronchodilator.
Treatment with QVAR RediHaler should be discontinued and alternate
therapy instituted
- Hypersensitivity reactions:
Hypersensitivity reactions, such as urticaria, angioedema, rash,
and bronchospasm, may occur after administration of QVAR RediHaler.
Discontinue QVAR RediHaler if such reactions occur
- Hypercorticism and Adrenal
Suppression: It is possible that systemic corticosteroid
effects such as hypercorticism and adrenal suppression may appear
in a small number of patients, particularly at higher than
recommended doses. If such changes occur, reduce the QVAR RediHaler
dose slowly, consistent with accepted procedures for reducing
systemic corticosteroids and for management of asthma symptoms
- Effects on Growth: Orally
inhaled corticosteroids, including QVAR RediHaler, may cause a
reduction in growth velocity when administered to pediatric
patients. Routinely monitor the growth of pediatric patients
receiving QVAR RediHaler. To minimize the systemic effects, titrate
to the lowest dosage that effectively controls symptoms
- Reduction in Bone Mineral Density
(BMD): Decreases in bone mineral density have been observed
with long-term administration of products containing inhaled
corticosteroids. Patients with major risk factors for decreased
bone mineral content should be monitored and treated with
established standards of care
- Eye Disorders: Glaucoma,
increased intraocular pressure, blurred vision and cataracts have
been reported following the long-term administration of inhaled
corticosteroids. Therefore, close monitoring is warranted in
patients with a change in vision or with a history of increased
intraocular pressure, blurred vision, glaucoma, and/or
cataracts
- Adverse Reactions: Most common
adverse reactions (incidence ≥3% and >placebo) include oral
candidiasis, upper respiratory tract infection, nasopharyngitis,
allergic rhinitis, oropharyngeal pain and sinusitis.
Please click here for full Prescribing Information:
http://www.qvarredihaler.com/pdf/PI.pdf
A copy may be requested from the US Medical Information Contact
Center for Teva Specialty Medicines at 888-4-TEVA-RX (888-483-8279)
and USMedInfo@tevapharm.com or Teva’s Public Relations or Investor
Relations contacts.
About Teva RespiratoryTeva Respiratory develops and
delivers treatment options for respiratory conditions, including
asthma, COPD and allergic rhinitis. The Teva Respiratory portfolio
is centered on optimizing respiratory treatment for patients and
healthcare providers through the development of novel delivery
systems and therapies that help address unmet needs. The company’s
respiratory pipeline and clinical trial program are based on drug
molecules delivered in proprietary dry powder formulations and
breath-actuated device technologies, as well as a targeted biologic
treatment for severe asthma. Through research and clinical
development, Teva Respiratory continually works to expand,
strengthen and build upon its treatment portfolio to positively
impact the lives of the millions of patients living with
respiratory disease.
About TevaTeva Pharmaceutical Industries Ltd. (NYSE and
TASE: TEVA) is a leading global pharmaceutical company that
delivers high-quality, patient-centric healthcare solutions used by
millions of patients every day. Headquartered in Israel, Teva is
the world’s largest generic medicines producer, leveraging its
portfolio of more than 1,800 molecules to produce a wide range of
generic products in nearly every therapeutic area. In specialty
medicines, Teva has a world-leading position in innovative
treatments for disorders of the central nervous system, including
pain, as well as a strong portfolio of respiratory products. Teva
integrates its generics and specialty capabilities in its global
research and development division to create new ways of addressing
unmet patient needs by combining drug development capabilities with
devices, services and technologies. Teva's net revenues in 2015
amounted to $19.7 billion. For more information, visit
www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding QVAR® RediHaler™, which are based on management’s
current beliefs and expectations and are subject to substantial
risks and uncertainties, both known and unknown, that could cause
our future results, performance or achievements to differ
significantly from that expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to:
- the potential benefits and uncertainty
of commercial success of QVAR® RediHaler™;
- our specialty medicines business,
including: competition for our specialty products, especially
Copaxone®, our leading medicine, which faces competition from
existing and potential additional generic versions and
orally-administered alternatives; challenges inherent in product
research and development, uncertainty of clinical success and
obtaining regulatory approvals as well as our ability to achieve
expected results from investments in our product pipeline;
competition from companies with greater resources and capabilities;
and the effectiveness of our patents and other measures to protect
our intellectual property rights;
- our business and operations in general,
including: our ability to develop and commercialize additional
pharmaceutical products; manufacturing or quality control problems,
which may damage our reputation for quality production and require
costly remediation; interruptions in our supply chain; disruptions
of our or third party information technology systems or breaches of
our data security; the restructuring of our manufacturing network,
including potential related labor unrest; the impact of continuing
consolidation of our distributors and customers; and variations in
patent laws that may adversely affect our ability to manufacture
our products;
- compliance, regulatory and litigation
matters, including: costs and delays resulting from the extensive
governmental regulation to which we are subject; the effects of
reforms in healthcare regulation and reductions in pharmaceutical
pricing, reimbursement and coverage; potential additional adverse
consequences following our resolution with the U.S. government of
our FCPA investigation; governmental investigations into sales and
marketing practices; potential liability for sales of generic
products prior to a final resolution of outstanding patent
litigation; product liability claims; increased government scrutiny
of our patent settlement agreements; failure to comply with
complex Medicare and Medicaid reporting and payment
obligations; and environmental risks; and other factors discussed
in our Annual Report on Form 20-F for the year ended December
31, 2016 (“Annual Report”), including in the section captioned
“Risk Factors,” and in our other filings with the U.S.
Securities and Exchange Commission, which are available at
www.sec.gov and www.tevapharm.com. Forward-looking statements speak
only as of the date on which they are made, and we assume no
obligation to update or revise any forward-looking statements or
other information contained herein, whether as a result of new
information, future events or otherwise. You are cautioned not to
put undue reliance on these forward-looking statements.
###
1. American Thoracic Society, Rescue Inhaler Study: New Approach
Increases Mastery of Life-Saving Technique, March 18, 2016.
Available at:
https://www.thoracic.org/about/newsroom/press-releases/journal/rescue-inhaler-study-new-approach-increases-mastery-of-life-saving-technique.php.
Accessed on May 25, 2016.
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Teva Pharmaceutical Industries Ltd.IR:United StatesKevin C.
Mannix, 215-591-8912orRan Meir, 215-591-3033orIsraelTomer Amitai,
972 (3) 926-7656orPR:IsraelIris Beck Codner, 972 (3)
926-7246orUnited StatesDenise Bradley, 215-591-8974
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